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The National Vaccine Program Office provides strategic leadership and management and encourages collaboration and coordination among federal agencies and other stakeholders whose mandate is to help reduce the burden of preventable infectious disease. We offer thorough reporting, unbiased advice and expertise to other agencies in identifying and responding to gaps in the vaccine system, making vaccines safer and more effective for all.

  • NCHR (not gov't), The Vaccines for Children Program (VFC)
    • Quotes that “children who are eligible for VFC vaccines are entitled to receive those vaccines recommended by the Advisory Committee on Immunization Practices”; notes that states can charge an admin fee, capped at $15.

More news

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Specific vaccines

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Cases

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Pandemic response

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Supp

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Van Wyk v. Norden Laboratories, Inc., 345 N.W.2d 81 (Iowa, 1984)

A large number of cattle owned by the plaintiffs became sick shortly after injection of a vaccine produced by the defendant Norden Laboratories, Inc. and this suit followed. While several theories of liability were asserted by the plaintiffs, the court submitted only one: the implied warranty of fitness for a particular purpose (Iowa Code section 554.2315). The defendant appeals from a judgment for the plaintiffs, arguing that the court erred in submitting this theory under the facts of the case. It contends the implied warranty of fitness did not fit, so to speak. The plaintiffs cross-appeal, complaining that it was error to exclude certain expert evidence and to refuse submission of their alternative theories of strict liability and implied warranty of merchantability. We reverse on both appeals and remand.

"The warranty of fitness under [§] 554.2315 is said to turn on the 'bargain-related' facts as to what the seller had reason to know about the buyer's purpose for the goods and about his reliance on the seller's skill or judgment in selecting them." Van Wyk v. Norden Labs., Inc., 345 N.W.2d 81, 84 (Iowa 1984).

Van Wyk, 345 N.W.2d 81, 85 (concluding that the "implied warranty of fitness for a particular purpose" was inapplicable where a vaccine was sold to veterinarians for ordinary use, and the veterinarians subsequently used the vaccine on the plaintiffs' calves and "[t]here was no evidence that the seller had reason to know of any purpose for the plaintiffs' use of the vaccine, other than its ordinary use").

The few cases that are factually similar to this one support a claim in strict liability. In Alman Brothers Farms & Feed Mill, Inc. v. Diamond Laboratories, Inc., 437 F.2d 1295 (5th Cir.1971), for example, farmers injected their hogs with a modified live-virus hog cholera vaccine. Most of the hogs died from cholera and the plaintiff's expert testified the deaths were probably caused by the vaccine. The Fifth Circuit upheld a plaintiff's verdict (in a § 402A action) on sufficiency of the evidence grounds on facts somewhat similar to ours. That court also refused to set aside the verdict on the ground that the plaintiffs had not proven a specific defect in the product. The test was not to be whether a specific defect could be identified, but rather whether the product was unreasonably dangerous. Id. at 1302.

Texas specifically has endorsed strict liability where cattle sickened and died following a serum injection. O.M. Franklin Serum Co. v. C.A. Hoover & Son, 418 S.W.2d 482 (Tex.1967). A federal district court applying Mississippi law also found "no good reason why strict liability should not be applicable to this case since modified live virus vaccine [for hog cholera] is not an experimental drug, but a well-established one with known capabilities." Denman v. Armour Pharmaceutical Co., 322 F.Supp. 1370, 1374 (N.D.Miss.1970) (plaintiffs failed to prove defect or proximate cause). Van Wyk v. Norden Laboratories, Inc., 345 N.W.2d 81 (Iowa, 1984)

Brown v. Briscoe, 998 F.2d 201, 204 (4th Cir.1993) (upholding sua sponte dismissal of an inmate's §1983 claim where a nurse administered a vaccination even though the inmate informed her he had already received one) Watkins v. Jones (D. S.C., 2018)

Garcia v. N.Y.C. Dep't of Health & Mental Hygiene, 2018 NY Slip Op 4778 (N.Y., 2018) Garcia v. N.Y.C. Dep't of Health & Mental Hygiene, 2018 NY Slip Op 4778 (N.Y., 2018)

On this appeal, respondents the New York City Department of Health and Mental Hygiene (the Department), the New York City Board of Health (the Board), and Dr. Mary Travis Bassett, as Commissioner of the Department, argue that Supreme Court and the Appellate Division erred by enjoining enforcement of the Board's amendments to the New York City Health Code mandating that children between the ages of 6 months and 59 months who attend city-regulated child care or school-based programs receive annual influenza vaccinations. We agree. The Board's promulgation of the flu vaccine rules falls squarely within the powers specifically delegated to the Department in New York City Administrative Code § 17-109, and the Board's actions did not violate the separation of powers doctrine. Further, the flu vaccine rules are not preempted by state law. Garcia v. N.Y.C. Dep't of Health & Mental Hygiene, 2018 NY Slip Op 4778 (N.Y., 2018)

Blanks v. Univ. of Or. (D. Or., 2018)

Part of plaintiff's responsibilities as a registered nurse required her to monitor the Digital Data Loggers ("DDL") for the vaccine refrigerators to ensure compliance with Center for Disease Control ("CDC") and Vaccine for Children ("VFC"). In October 2016, the temperature range for the stored flu vaccinations went out of compliance during an off-site clinic. Plaintiff brought this to Cantwell's attention. This issue happened again later that same month for a separate clinic. Plaintiff reported this issue to the clinic's Medical Director, Dr. Brunander, and alleges that Cantwell falsified a report related to this incident. Plaintiff filed a complaint against Cantwell to the Oregon Board of Nursing in January 2017 with respect to the falsifying of that report. Blanks v. Univ. of Or. (D. Or., 2018)

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Plaintiff claims her First Amendment rights under 42 U.S.C. § 1983 were violated when Cantwell and Gutierrez retaliated and discriminated against her after she "exercised her free speech to object to unsafe and unlawful storage and handling of vaccines used to inoculate the public." Compl. ¶ 57. Defendant moves to dismiss this claim, arguing that the speech in question is not protected under the First Amendment and that Cantwell and Gutierrez are entitled to qualified immunity. Blanks v. Univ. of Or. (D. Or., 2018)

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Plaintiff argues that the proper handling of vaccines is a public health concern. Speech is a matter of public concern when it can be said to involve any matter of political, social, or other concern to the community. Huppurt v. City of Pittsburg, 574 F.3d 696 (9th Cir. 2009). The Ninth Circuit has held that speech involving the ability of a hospital to adequately care for patients was a matter of public concern. See Ulrich v. City & County of San Francisco, 308 F.3d 968, 978 (9th Cir. 2002) (holding that the physician's statements criticizing layoffs of other physicians was a matter of public concern because it influenced the ability of the hospital to adequately care for the patients). I find that the handling of vaccines, which will inevitably be used throughout the community, is indeed a concern to the community. Blanks v. Univ. of Or. (D. Or., 2018)

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Next, in determining whether plaintiff spoke as a private citizen or public employee, I must: (1) make a factual determination of plaintiff's job responsibilities and (2) resolve whether plaintiff's speech was made pursuant to her job duties. Kennedy, 869 F.3d at 823-824. This inquiry should not just look at the job description but what the employee actually does. Garcetti v. Ceballos, 547 U.S. 410, 424 (2006). Defendants argue that plaintiff was required to report the falsification of temperature records pursuant to her job duties. Plaintiff argues she was obligated to report the falsification of temperature records by Or. Rev. Stat. § 678.135, and this duty is independent from her employment with UO. However, plaintiff provides this Court no reason to treat her job responsibilities and statutory obligations separately under this step of the analysis. As a registered nurse, she had an obligation to report this kind of misconduct, but more importantly that obligation was directly within the scope of her employment with UO. Thus plaintiff does not meet her burden under step two, and this claim is dismissed. Alternatively, [Page 8] defendants Cantwell and Gutierrez are entitled to qualified immunity as the allegedly violated right was not clearly established at the time of the challenged conduct. Blanks v. Univ. of Or. (D. Or., 2018)

Sinovac Biotech Ltd. v. 1Globe Capital LLC (D. Mass., 2018)

Case involving alleged securities fraud.

In December 2016, an online report disclosing Chinese court documents revealed that Yin and other Sinovac employees bribed multiple Chinese officials from 2002 to 2011 to get vaccine trials approved and distribution of vaccines permitted.

FOLLOW UP (this is just a motion to intervene, need to see what else happened in the case)

Dotter v. Merck & Co. (In re Zostavax (Zoster Vaccine Live) Prods. Liab. Litig.) (E.D. Pa., 2018)

Plaintiff Jerome Dotter filed this action against Merck for injuries allegedly suffered from Zostavax, a vaccine to prevent shingles. Plaintiff Sheryl Greene-Payne makes a claim for loss of consortium.

Canuto v. Glaxosmithkline (D. D.C., 2018)

As the Court found, Ms. Canuto had two options after she received the Federal Circuit's decision denying relief under the Act: accept the judgment or reject it by filing a tort claim in federal or state court. Id. at 2-3. By not filing a civil action within 90 days, Ms. Canuto was "deemed to have filed an election to accept the judgment of the court." 42 U.S.C. § 300aa-21(a). The Vaccine Act bars civil litigation by claimants who accept the judgment of the court. Id. § 300aa-11(a)(2)(A). Accordingly, under § 300aa-11(a)(2)(B), the Court was required to dismiss the action against Pfizer for lack of jurisdiction.

The Court sees no reason why the same is not also true with respect to the federal defendants, and Ms. Canuto fails to provide one. Instead, she suggests that she did in fact timely reject the judgment of the Federal Circuit. She explains that she "used the 90 days of the final judgment of the Federal Circuit (42 U.S.C. & 300aa-21(a)) in filing a Writ of Certiorari to the Supreme Court (Supreme Court Case No. 16-1222) but the petition was denied on June 5, 2017." Pl.'s Opp'n to Federal Defs.' MTD, ECF No. 37, at 10-11. Only after the Supreme Court denied her petition for certiorari did Ms. Canuto file this action. The Court interprets this argument to be that Ms. Canuto functionally rejected the judgment of the Federal Circuit by seeking review of that judgment in the Supreme Court. That, however, was not enough to comply with the clear requirements of § 300aa-21. Under that section, Ms. Canuto was required to file with the clerk of the United States Court of Federal Claims "an election in writing . . . to file a civil action for damages" in order to then proceed in state or federal court. 42 U.S.C. § 300aa-21; id. §§ 300aa-11(a)(2)(A) & (B). Under the plain language of the statute, Ms. Canuto could not have satisfied the requirement that she file this election with the clerk of the Court of Federal Claims by filing a petition for certiorari with the Supreme Court.

Accordingly, the Court will grant the federal defendants' motion to dismiss for lack of jurisdiction pursuant to 42 U.S.C. § 300aa-11(a)(2)(B).

ANIMAL VACCINES

Smith v. First State Animal Ctr. (Del. Super., 2018)


KCSPCA unfortunately failed to administer vaccinations it was required to administer to Millie within the prescribed time frame.35 Millie was quarantined on March 20 after she attacked another dog on March 16. She was held in State custody pending a hearing on her classification as a dangerous dog on April 13, 2015. At the time Millie was quarantined, Defendant Palacio had been able to confirm with Savannah Animal Hospital that Millie was current on all of her vaccinations. Millie was eligible for vaccination pursuant to 16 Del. C. § 3002F(b) at the time her quarantine period ended, on March 25. Millie was ultimately vaccinated as required on April 8. In fact, Smith now claims she was over-vaccinated and this over-vaccination left her susceptible to health problems. Smith testified Millie was returned to them with a case of pneumonia, which he claims can be traced to the Defendants' failure to vaccinate Millie within seventy-two hours, and anxiety, which can be traced to Millie's experience at the kennel. Notably, there has been no medical testimony, records, or bills for treatment introduced to support this claim.

At the time unaware that Millie had not been vaccinated as required, Smith sent an independent veterinarian to inspect Millie at the Shelter. This veterinarian was not permitted to examine Millie. Defendant Usilton testified Defendant Warburton informed him that an outside veterinarian wanted to see Millie. "I asked if it was Millie's regular veterinarian and she said no. Then I said there's no reason for her to see her. We have our own veterinarian on staff who would be happy to look at anything that Millie would have."36 Defendant Usilton testified that no one had sent an independent veterinarian to inspect an animal at the Shelter before and that he likely would have permitted Millie's regular veterinarian to see her. But, Defendant Usilton reasoned, there was policy in place pursuant to which any medical ailments of Millie's would be attended. All told, Millie spent less than a month in State custody.

Viewing the facts in a light most favorable to Smith, neither the inaction by Defendant KCSPCA to vaccinate Millie within seventy-two hours of the end of her quarantine nor the alleged over-vaccination resulted in a diagnosable health problem for either Millie or Smith. Similarly, Smith has failed to show how the failure to permit an independent veterinarian to examine Millie resulted in distress to either the dog or her owner. The alleged distress caused to Smith as a result of the Shelter's actions and inaction was not "so severe that no reasonable person could be expected to endure it."37 Millie's treatment at the Shelter is not sufficient to sustain a claim for intentional infliction of emotional distress. Smith v. First State Animal Ctr. (Del. Super., 2018)

CFC PRIVACY

Gipson v. Sec'y of Health & Human Servs. (Fed. Cl., Oct. 1, 2018)

Although this Ruling has been formally designated "not to be published," it will nevertheless be posted on the Court of Federal Claims's website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the Ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Ruling's inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction "of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy." Vaccine Rule 18(b). Otherwise, the Ruling in its present form will be available. Id.

SPECIAL MASTER = JUDICIAL IMMUNITY

Miller v. Dorsey (D. Neb., 2018)

The Vaccine Act sets forth a method for compensation for vaccine-related injuries or death. 42 U.S.C. § 300aa-11. Congress enacted the Vaccine Act to streamline the process of seeking compensation for vaccine-related injuries and to avoid the inconsistency, expense, and unpredictability of the tort system. See Shalala v. Whitecotton, 514 U.S. 268, 270 (1995) ("For injuries and deaths traceable to vaccinations, the Act establishes a scheme of recovery designed to work faster and with greater ease than the civil tort system."). Under the Vaccine Act, plaintiffs may not file a civil action in state or federal court against a vaccine manufacturer or administrator unless they first file a timely petition in the Court of Federal Claims. See 42 U.S.C. § 300aa-11(a)(2)(A); Whitecotton, 514 U.S. at 270, (explaining that a claimant alleging an injury after the Vaccine Act's effective date "must exhaust the Act's procedures . . . before filing any de novo civil action in state or federal court"). After proceeding through the Court of Federal Claims, a claimant may pursue a civil tort action in either state or federal court by filing a notice of election to file a civil suit. 42 U.S.C. § 300aa-21(a).

The plaintiffs have sued Chief Special Master Dorsey and Martin (collectively "the Federal Defendants") in their official and individual capacities for declaratory relief, alleging the Federal Defendants violated the plaintiffs' Fifth Amendment due process rights in connection with the Federal Claims Court proceedings under the Vaccine Act. Because Chief Special Master Dorsey and Martin are federal officials, the plaintiffs' claims against them arise under Bivens, supra. However, while a Bivens action may be maintained against federal officials in their individual capacity for constitutional torts committed personally, such an action may not be asserted against the United States, its agencies, or against federal employees in their official capacity. FDIC v. Meyer, 510 U.S. 471, 473, 484-86 (1994); Balser v. Department of Justice, Office of U.S. Trustee, 327 F.3d 903, 909 (9th Cir.2003), cert. denied, 541 U.S. 1041 (2004). Thus, the plaintiffs' Bivens action does not state a viable cause of action against the defendants in their official capacity. Balser v. Department of Justice, Office of U.S. Trustee, 327 F.3d at 909.

In their individual capacities, Chief Special Master Dorsey and Martin would be shielded by absolute immunity if the plaintiffs were seeking damages from them. See Mireles v. Waco, 502 U.S. 9, 11 (1991) (judges are entitled to absolute judicial immunity from damages for acts taken while in their judicial capacity unless they acted in the clear absence of all jurisdiction, and absolute judicial immunity is not overcome by allegations of bad faith or malice); Murphy v. Morris, 849 F.2d 1101, 1105 (8th Cir. 1988) (citing Barrett v. United States, 798 F.2d 565, 571-73 (2d Cir. 1986)) (government defense counsel's "function as a government advocate entitles him or her to absolute immunity from suit for damages"). Because the plaintiffs only seek declaratory relief against the Federal Defendants, absolute immunity does not bar their claims. See Moore v. Gerrard, No. 4:15CV3140, 2016 WL 8376696, at *2 (D. Neb. Feb. 22, 2016), aff'd, 667 F. App'x 582 (8th Cir. 2016) (citing Lawrence v. Kuenhold, 271 Fed.Appx. 763, 766 (10th Cir. 2008)). Nonetheless, the plaintiffs are not entitled to declaratory relief. The plaintiffs ask for a declaration that the vaccines mentioned in the Complaint injured A.M., contrary to Chief Special Master Dorsey's conclusion in the Federal Claims Court proceedings. (Filing No. 1 at CM/ECF p. 7.) Essentially, the plaintiffs ask the court to declare that the Federal Defendants violated the plaintiffs' due process rights and the Vaccine Act in concluding that the vaccines did not injure A.M. This is a request for a declaration of past liability and such declaration would not pertain to the plaintiffs' future rights. Lawrence, 271 Fed.Appx. at 766 ("A declaratory judgment is meant to define the legal rights and obligations of the parties in anticipation of some future conduct, not simply to proclaim liability for a past act."). Thus, a declaratory judgment would serve no purpose and is not available. Id.; see also Moore, supra. The plaintiffs' claims against the Federal Defendants must therefore be dismissed.

Notification

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Notification of exposure to measles/other diseases

Testing on humans

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In Iron Cloud v. Sullivan, 984 F.2d 241 (8th Cir., 1993) a district court dismissed an action to halt the testing of a hepatitis A vaccine on Native American children in North and South Dakota. The complaint alleged "that parents were asked to give informed voluntary consent to their children's participation in the studies even though the government provided incomplete, misleading, and inaccurate information regarding the scope of the testing programs and the safety of the vaccine."

"Ordinarily, a vaccine-testing program of this nature takes years to complete, and the adequacy of informed consent to participate in such a program may be challenged in the earliest stages of the program." Iron Cloud v. Sullivan, 984 F.2d 241, 243 (8th Cir., 1993)

Anti-vaccine

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Vaccines for animals

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Private mandates

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Health care workers

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Social media efforts

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Vaccine naming

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Further material

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Volume 44, No.11, 2015 Pages 849-852

  • Mandatory vaccination and no fault vaccine injury compensation schemes: An identification of country-level policies

Katie Attwell, Shevaun Drislane, Julie Leask

End matter

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